The increasing adoption of closed-loop systems in medical technology presents novel and multi-dimensional cybersecurity challenges. This presentation examines the critical issues and regulatory frameworks related to the security of closed-loop medical devices, with a particular emphasis on the EU Medical Device Regulation (MDR) and the U.S. Food and Drug Administration (FDA) guidelines. These systems, which autonomously measure, interpret physiological parameters, and execute therapeutic decisions without human intervention, introduce unique risks and vulnerabilities. Key concerns include potential attack vectors targeting sensors, actuators, and control algorithms.

The discussion provides a comparative analysis of MDR and FDA requirements, focusing on their respective approaches to risk management, software development, and post-market surveillance. Special attention is given to FDA guidance on "physiological closed-loop controlled" devices, which sets out specific safety and performance standards for these advanced systems.  A case study is presented here for context into the challenges in securing closed-loop technologies.

The presentation concludes with evidence-based recommendations for manufacturers to ensure robust cybersecurity across the entire lifecycle of closed-loop medical devices. These recommendations address the dynamic and evolving threat landscape, as well as shifting regulatory requirements. By advocating for a proactive and integrated approach to cybersecurity, the discussion highlights the importance of addressing the unique risks associated with closed-loop systems to ensure patient safety and the reliability of these healthcare technologies.